Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The instant application having Application No. 18568151 filed on 05/20/2022 is presented for examination by the examiner.
Election/Restriction
Applicant’s election of Invention group II, claims 30-44 in the reply filed on 01/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 23-29 are withdrawn by the Applicant from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/13/2026.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Priority
As required by e M.P.E.P. 210, 214.03, acknowledgement is made of applicant’s claim for priority based on application of National Stage entry of PCT/EP2022/063724 , International Filing Date: 05/20/2022 that claims foreign priority to DE 10 2021 205 738.1, filed 06/08/2021
(Germany).
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
However, to overcome a prior art rejection, applicant(s) must submit a translation of the foreign priority papers in order to perfect the claimed foreign priority because said papers has not been made of record in accordance with 37 CFR 1.55. See MPEP § 213.04
Drawings
The applicant’s drawings submitted are acceptable for examination purposes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 30-35 are rejected under 35 U.S.C. 103 as being unpatentable over Neal et al. (hereafter Neal, of record) US 20170027437 A1 and Hallen (of record) US 20190099226 A1.
In regard to independent claim 1, Neal teaches (see Figs. 1-16) a of method of diagnosis, and of planning, monitoring or both planning and monitoring a course of an operation on an eye (i.e. as optical imaging and measurement system(s) 1 and methods involving 1 and assembly 100, e.g. methods for diagnostics, cataract surgery and treatment planning, see abstract, paragraphs [4,7-27,51, 55-63, 65-66,68-92,99-110,115-122], e.g. Figs. 1-3,6,8), the method comprising (method of 1,100) comprising:
projecting a fixation mark into the eye with a light source (i.e. as projecting fixation target of fixation target subsystem, 50,180 with source 182, 130, for eye alignment with 102 optical central axis, paragraphs [11,65-66,77-81,99,118-122]);
imaging light of the fixation mark that is reflected, diffracted, or scattered by a cornea, a lens, and a retina of the eye on an image sensor (i.e. as reflected light from cornea, lens (incl IOL), retina, from sources e.g. 152,120, 130, 201,202 and received imaged/detected by 155,141, 220, paragraphs [81-92,99-110], Figs. 2-3, 5-7);
detecting, by application of a control unit, reflections and light of the fixation mark diffracted and scattered by eye structures in images transmitted by the image sensor to the control unit (i.e. as detecting by controller/processor e.g. 60 that receives image data from detectors above including reflection images, spots of light from 130, 120,152, and performs image analysis, paragraphs [63-64,75,81,87,91, 99-101,118-126,133136-138]);
recording dynamic range (HDR) images of the eye by application of an HDR digital camera predominantly only in a case of an activated fixation illumination (i.e. as using high resolution camera e.g. 220,155,141 for high resolution images and measurements of the whole eyes, and imaging by system including 220 and 60 is while 180 is active and projects fixation target, paragraphs [11, 65-66, 85, 76,91-97, 99-112,118-122], e.g. Figs. 2-3, 8-11), and
optimizing and evaluating the HDR images; and displaying the HDR images on a display by operation of the control unit. (i.e. as 60 carries out image processing analysis and optimization of captured image light, and displays on display e.g. 7, 70, paragraphs [51, 54-63, 99-101,118-127,133136-138,149], Figs. 1-3, 6-11).
Neal does not expressly disclose that the HDR digital camera (high resolution camera detectors) recording high dynamic range HDR images (i.e. as noted imaging detectors are high resolution detectors, e.g. 220, 155,141, paragraphs [85, 76,91-97, 100-112]).
However, this feature is obvious over Hallen (of record), as Hallen teaches ophthalmic surgery and system integration of high dynamic range HDR digital camera that records high dynamic range HDR images (e.g. as high dynamic range digital camera system, imaging HDR images in ophthalmic procedures, e.g. paragraphs [01-14, 35-41], and can be used to capture a multidimensional visualization of a patient's eye that can be transmitted to a high-definition display, e.g. allowing a surgeon to conduct surgery in a heads-up posture]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt and modify the recording with digital high resolution detector camera of Neal to explicitly include recording high dynamic range (HDR) images of the eye with application of HDR digital camera according to teachings of Hallen in order to apply such HDR digital camera producing HDR images in ophthalmic procedures to capture a multidimensional visualization of a patient's eye that can be transmitted to a high-definition display, e.g. allowing a surgeon to conduct surgery in a heads-up posture, and provide a resolution, image depth, clarity and color contrast that enables a high quality, three-dimensional image of patient anatomy (e.g. paragraphs [01-03, 35-36]).
Regarding claim 31, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising detecting the fixation mark in the images transmitted by the image sensor by application of the control unit, and thus monitoring alignment of the eye in relation to an optical axis of the device and displaying said alignment on a display (i.e. as detecting by controller/processor e.g. 60 that receives image data from detectors noted above, and performs image analysis including reflection images, spots of light from 130, 120,152, and performs image analysis and alignment, e.g. including identification of patient movement between and/or during measurement sequence, paragraphs [63-64,75,81,87,91, 99,103,112,115-126]).
Regarding claim 32, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising recording HDR images of the eye by application of the digital camera with an intensity depth/color depth selected from a group consisting of more than 8 bits, 10 to 14 bits and 16 bits or more (i.e. as per combination with Hallen given that high dynamic range digital camera system having high resolution, image depth, clarity and color contrast that enables a high quality, three-dimensional image of patient anatomy, recording HDR images in ophthalmic procedures, paragraphs [01-14, 35-41], has digital bits in the above range as digital high dynamic range (HDR) imaging cameras typically utilize a bit depth of 12-bit to 16-bit per channel for raw capture, allowing for 212 to the 216 levels of brightness to handle extreme contrast. In the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize and specify recording HDR images with digital camera having intensity depth/color depth of more than 8 bits in order to capture a multidimensional visualization of a patient's eye that can be transmitted to a high-definition display, e.g. allowing a surgeon to conduct surgery in a heads-up posture (see e.g. paragraphs [01-03, 35-36]), and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955).
Regarding claim 33, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising recording the HDR images of the eye telecentrically (i.e. as imaging with telecentric detection system, paragraphs [63-64, 78], Figs. 3A-B).
Regarding claim 34, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising suppressing ambient light for a purpose of recording the eye images (i.e. as imaging with system 1 includes using main unit 2 with patient interface 4, with 5, 6 serving as hood/shield of external light, and also as housing 200 of OCT unit as depicted in Figs. 1A-C, paragraphs [51-54, 92]).
Regarding claim 35, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising using known image processing and image optimization methods to optimize and evaluate the HDR images of the eye (i.e. as using 60 to carries out image processing and analysis and optimization for resolving different regions of the eye of captured HDR image(s) light, paragraphs [51, 54-63, 75-76, 81, 87, 91, 99-101,118-127,133136-138,149], Figs. 1-3, 6-11).
Claims 36-44 are rejected under 35 U.S.C. 103 as being unpatentable over Neal et al. (hereafter Neal, of record) US 20170027437 A1 and Hallen (of record) US 20190099226 A1, and further in view of Imamura US 20160317015 A1.
Regarding claim 36, the Neal-Hallen combination teaches the invention and method as set forth above, and Neal further teaches comprising optimizing and evaluating the IDR images of the eye (i.e. as using 60 to carries out image processing and analysis and optimization for resolving different regions of the eye of captured HDR image(s) light, paragraphs [51, 54-63, 75-76, 81, 87, 91, 99-101,118-127,133136-138,149], Figs. 1-3, 6-11) by:
b) optimizing the intensity image representation to obtain a "moon-like" pupil image of the eye (i.e. as best understood, given the ambiguity of the term, e.g. optimization for resolving different regions of the eye of captured HDR image, paragraphs [81, 87, 91, 99-101], see also color image optimization with surgical suite optimization engine of Hallen, paragraphs [38-45,102-103 ;
c) detecting a pupil edge and determining a diameter (i.e. as pupil size, position, paragraphs [115-117]);
d) comparing the diameter with an expected value (i.e. including iris/pupil image comparison, e.g. determine the corneal topography, paragraphs [75, 81, 162]);
e) performing dilation should the diameter be too small and renewing performance of steps a) to d) (i.e. analysis of retroreflection of illuminators when pupil is dilated, e.g. paragraphs 81-82]);
f) should the diameter at least correspond to the expected value, detecting image content in respect of abnormalities (e.g. presence, indication of corneal abnormality, e.g. paragraphs [99-100], e.g. see Figs. 8-11). The Neal-Hallen combination doesn’t expressly disclose removing image noise.
However, Imamura teaches in the same field of invention of information processing apparatus including an image acquiring unit configured to acquire a plurality of types of images of an eye (see Figs. 1-12, title, abstract, paragraphs [02,09-11,32-40, 43-55, 70, 81-90, 113-127]) and further teaches removing image noise (i.e. as part of image processing as image processing unit 130 removes high-frequency components, noise and other peak components other than the photoreceptors in the confocal and non-confocal images, paragraphs [70, 87, 113,127]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the optical imaging and measurement system and methods of Neal and Hallen to include removing image noise method(s) step, according to teachings of Imamura in order to remove image noise and obtain corrected images without blurring the features of the image (see Imamura, paragraphs [70, 87, 113,127]).
Regarding claim 37, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under step f) comprise shadow regions which indicate a cataract or posterior capsular opacification (i.e. as diagnosed regions with cataract, see abstract, paragraphs [02, 07-08, 40-44,146-148]).
Regarding claim 38, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) comprise shadow regions which facilitate determination of a stage of cataract of the lens (i.e. as diagnosed regions with cataract, see abstract, paragraphs [02, 07-08, 40-44,146-148]).
Regarding claim 39, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) represent a basis for further clinical examinations of the eye (e.g. additional operational sequence and method in which OCT measurements utilizing the OCT subsystem and Iris images using the iris imaging subsystem may be taken simultaneously in order to improve three dimensional modeling of the patient's eye, Figs. 10-11, and/or further cataract treatment planning paragraphs [123-127,148,151]).
Regarding claim 40, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) represent a basis for an OCT-B-scan to be performed in accordance with the observed eye information, to determine the area/stage of the cataract and to obtain further clinically meaningful OCT depth information for the examined eye (performing X-scan or Y-scan sequence and method in which OCT measurements utilizing the OCT subsystem, paragraphs [123-127,148,151], Figs. 8-11).
Regarding claim 41, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) also comprise the edge of an IOL, the markers thereof present or both, thereby facilitating deducing the position of the IOL the orientation of the IOL or both (i.e. presence of IOL position and orientation, e.g. paragraphs [82, 146-151, 155-158]).
Regarding claim 42, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) comprise 3rd and 4th Purkinje reflexes, thereby facilitating determining tilt of an IOL, centration of the IOL or both in the eye (i.e. given retroreflection spots for detected IOL position, orientation and tilt and decentration, paragraphs [04,12,16-20,82,155-162]).
Regarding claim 43, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches that detected abnormalities under f) (e.g. presence, indication of corneal abnormality, e.g. paragraphs [99-100], e.g. see Figs. 8-11) and Hallen further teaches facilitate assessing size of a capsulorhexis quality of a capsulorhexis or both, (as surgical suite optimization engine facilitate receiving surgical procedure data for steps and/or phases of a particular procedure such as a capsulorhexis steps, with included optimal display positions based on surgical steps/phases and database storing surgeon preferences., see Hallen paragraphs [74-75]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the optical imaging and measurement system and methods of Neal and Hallen to include facilitating assessing size and/or quality of a capsulorhexis as receiving surgical procedure data for steps and/or phases capsulorhexis of Hallen in order to provide for capsulorhexis surgical data and septs and secure optimal display positions based on surgical steps/phases and database storing surgeon preferences (see Hallen paragraphs [74-75]).
Regarding claim 44, the Neal-Hallen-Imamura combination teaches the invention and method as set forth above, and Neal further teaches, recording with the digital camera a series of HDR images of the eye, to facilitate monitoring a function of a tear film (i.e. with camera 40, providing assessment of the tear film, e.g. paragraphs [107, 123-128]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Copland et al. US 20170095147 A1 also discloses features of instant invention (see Figs. 1-15 and their descriptions).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIN PICHLER whose telephone number is (571)272-4015. The examiner can normally be reached Monday-Friday 8:30am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas K Pham can be reached at (571)272-3689. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIN PICHLER/ Primary Examiner, Art Unit 2872